ندى Abdulla Kk

Associate clinical data coordinator في IQVIA

• الهند - بنغالورو
• فبراير 2022 إلى أكتوبر 2023

Conducts basic data review activities.
Meet various project objectives as assigned by the
manager.
Reviews clinical trial data in accordance with Global Data
Management Plans and applicable standardized data
management processes like SOPs, Work Instructions, etc.
to identify erroneous, missing, incomplete, or implausible
data.
Resolve data clarifications as directed by the Data
Operating Coordinator.
Develop and maintain good communication and working
relationships with the CDM team.
Escalates problems to the attention of the Data Operating
Coordinator or Group Manager in a timely manner.
Query management- Based on guidelines set forth in DMP
(Data Management Plan)/Data validation plan.
Managed and oversaw the collection, processing, and
analysis of clinical trial data, ensuring accuracy and
compliance with regulatory requirements.
Conducted quality control checks to ensure data integrity,
consistency, and completeness.
Collaborated with cross-functional teams including
investigators, site staff, and statisticians to resolve datarelated issues and discrepancies.
Generated and maintained standard operating
procedures (SOPs) to ensure adherence to regulatory
guidelines and industry best practices.
Participated in regulatory audits and inspection activities,
providing necessary data and documentation as required.
Assisted in the preparation and submission of regulatory
documents such as study protocols, informed consent
forms, and case report forms.
Stayed updated with the latest regulatory guidelines and
industry trends to ensure compliance with evolving
regulatory requirements.
SAS Listings review.
Manual Listings Review- Inactivated pages, Nonconformant data, Duplicate pages, Unsubmitted data
points, and Unsubmitted Forecasted pages using different
Data listing reports.
IPD Reconciliation with access to CTMS.